Table 3.
The main CE-IVD and/or emergency use authorization (EUA)-labelled integrated extraction/amplification platforms and sample-to-result assays for the detection of SARS-CoV-2.
| Assay | Manufacturer | Viral Genes | Assay/Equipment Type | Approx. Time-to-Result |
|---|---|---|---|---|
| Xpert® Xpress SARS-CoV-2 | Cepheid | N, E | RT-PCR/single test, sample-to-result | 45 min. |
| Vivalytic analyzer/Vivalytic VRI test | BOSCH | Na a | RT-PCR/single test, sample-to-result | 39 min. |
| VitaPCRTM platform/VitaPCR™ SARS-CoV-2 assay | Menarini | N | RT-PCR/single test, sample-to-result | 20 min |
| GenMark ePlex instrument/ePlex® SARS-CoV-2 Test | GenMark | N | RT-PCR/single test, sample-to-result | 90 min. |
| ARIES® SARS-CoV-2 Assay | Luminex Corporation | Orf1ab, N | RT-PCR/single test, sample-to-result | 2 h |
| ID Now COVID-19 | Abbott | RdRp | Isothermal amplification/single test, sample-to-result | 13 min. |
| Simplexa COVID-19 Direct assay | DiaSorin | orf1ab, S | RT-PCR/batch testing, sample-to-result | 80 min. |
| ELITech InGenius platform/SARS-CoV-2 ELITe MGB® Kit | ELITech | RdRp, Orf8 | RT-PCR/batch testing, sample-to-result | 2 h 30 min. |
| Cobas 6800/8800/cobas SARS-CoV-2 | Roche | orf1ab, E | RT-PCR/batch testing, sample-to-result | 3 h 30 min. |
| Alinity m System/Alinity m SARS-CoV-2 assay | Abbott | RdRp, N | RT-PCR/batch testing, sample-to-result | 2 h |
| NeoMoDx™ molecular system/NeuMoDx™ SARS-CoV-2 Assay | QIAGEN | Nsp2, N | RT-PCR/batch testing, sample-to-result | 80 min. |
| BD MAX™ System/BD SARS-CoV-2 Reagents | Becton Dickinson | N | RT-PCR/batch testing, sample-to-result | 3 h |
| Panther/Aptima SARS-CoV-2 assay | Hologic | orf1ab | Isothermal amplification/batch testing, sample-to-result | 3 h 30 min. |
| Seegene NIMBUS/STARlet/Maelstrom 9600/Allplex™ SARS-CoV-2 Assay | Seegene | RdRp, N, S, E | RT-PCR/batch testing, integrated equipment for extraction and amplification b | From 3 h 20 min. to 4 h 40 min. |
| KingFisher Flex Purification system/TaqPath™ COVID-19 RT-PCR Kit | Life Technologies Corporation | orf1ab, N, S | RT-PCR/batch testing, integrated equipment for extraction and amplification | na |
| BIOFIRE® Respiratory Panel 2.1 | Biomérieux | S, M | RT-PCR/syndromic panel, sample-to-result | 45 min. |
| QIAstat-Dx Respiratory SARS-CoV-2 Panel | QIAGEN | RdRp, E | RT-PCR/syndromic panel, sample-to-result | 60 min. |
a Not declared by the manufacturer. b Main assays using proprietary equipment for both extraction and amplification steps are reported.